Biotres

FDA 510(k) K222017 · Biotricity

Substantially Equivalent

510(k) numberK222017

Submission

Device name
Biotres
Applicant
Biotricity
Redwood City, CA, US
Received
July 8, 2022
Decision date
July 28, 2022
Decision
Substantially Equivalent (SESE)
Type
Special 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
MWJ – Electrocardiograph, Ambulatory (Without Analysis)
Device class
Class II (moderate risk)
Regulation
21 CFR 870.2800
Specialty
Cardiovascular

Other 510(k)s with product code MWJ

510(k)DeviceApplicantDecision
K254119Wearable ECG Recorder (YMHeart XY-12); Wearable ECG Recorder (YMHeart XY-1201); Wearable…MWJ · Traditional Shenzhen Xinyan Medical Technology Co.,ltd.09/11/2026SE
K253529Peerbridge COR MDx (Cor MDx)MWJ · Abbreviated Peerbridge Health, Inc.09/04/2026SE
K253562medilogFDMWJ · Traditional Schiller AG08/14/2026SE
K253384mobiCARE Cardiac Monitoring System (mobiCARE-MC200M, mobiCARE-MC200ML, mobiCARE-MC200M7…MWJ · Traditional Seers Technology Co., Ltd.06/25/2026SE
K252839ZywieZ3 Sensor & AdhesiveMWJ · Traditional Zywie, Inc.06/18/2026SE
K231424HeartBeam AIMIGo(TM) SystemMWJ · Traditional Heartbeam, Inc.12/13/2024SE
K233864ASSURE Wearable ECGMWJ · Traditional Kestra Medical Technologies, Inc.05/07/2024SE
K212317Eclipse MINI Model 98900MWJ · Traditional Spacelabs Healthcare, Ltd.11/07/2022SE
K210758Q PatchMWJ · Traditional Medicalgorithmics S.A.06/02/2022SE
K211709BiotresMWJ · Traditional Biotricity01/19/2022SE

More from Biotricity

510(k)DeviceDecision
K211709BiotresMWJ · Traditional 01/19/2022SE
K201040Bioflux Software IIDSH · Traditional 07/29/2020SE
K172311BioFlux DeviceDXH · Traditional 12/15/2017SE
K162571Bioflux SoftwareDSH · Traditional 10/13/2016SE

Questions and answers

When was Biotres cleared by the FDA?

Biotres (K222017) received a 510(k) decision of Substantially Equivalent on July 28, 2022, 20 days after the submission was received.

What is the product code of K222017?

The FDA product code is MWJ – Electrocardiograph, Ambulatory (Without Analysis), a Class II (moderate risk) device regulated under 21 CFR 870.2800.